RA & Medical Device Compliance Manager社

面议

苏州市本科及以上7年及以上

发布时间：2023-09-06

职位描述

Main tasks:
1. Preparation and maintenance of the regulatory documentation for products groups CaTS and Dialysers,
2. Support the activities of the PL QA & MDRA for the collection and preparation of technical, regulatory and biocompatibility information provided by internal or external functions (e.g. from suppliers)
3. Support the Product Line Quality function for products compliance and Medical Device related vigilance activities (e.g. complaints data review and contact with production sites, feedback to Authority requests, CAPA review, etc.); working also as Deputy of the PL Quality and MDRA.
4. Coordination of Risk Management activities for products groups CaTS and Dialysers Interface with R&D and other Corporate functions to keep up-to-date the technical documentation relevant for regulatory purposes (e.g. usability report, interface verification test report etc.)
5. Regulatory activities needed to maintain product compliance e.g. implementing new laws and / or regulations
6. Risk Management File Updates: Periodically or specific events (customer complaints, Design Changes, market surveys, etc.)
7. Supporting function in case of Notified Bodies / Authorities audits for the regulatory documentation review
8. Deputy of the PL Quality and MDRA of products groups CaTS and Dialysers for approving change requests, change activities as part of decision Board and/or regulatory documentation
9. Regulatory Affairs activity to support local registration
Secondary tasks:
1. Management of technical documentation requests from third parties or from other FME departments (e.g. QREM EMEA/AP);
2. Participate in new component / product development activities, as part of Cross Functional Teams, related to risk analysis activities and for providing regulatory expertise
3. Team member for performing pFMEA (participation for products, components, process in case of a design change)
4. Preparation of project plan, time plan and reporting for Regulatory related projects
Miscellaneous tasks:
1. Training to personnel on risk management activities (acc. to ISO14971) and techniques
2. Training to personnel on Regulatory Affairs matters (e.g. MDD/MDR regulations, REACH regulation etc.)
3. In charge for defining RA KPIs to be used for monitoring the overall regulatory process


Education:
Technical / Scientific background (degree)
Working Experience:
Experience of minimum 3 years in Regulatory Affair in pharmaceutical/medical field
Qualification:
1) High identification with and loyalty to the department (QS GMQS), the area (GMQS) and the Company
2) Good and professional relationship to and communication with colleagues, subordinates, superiors and to internal and external customers. Integrating attitude, leadership skills
3) High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross functional with all levels of employees
4) Organizational capacity and analytical ability
5) Autonomy in decision making 4) Other specialized knowledge: a) Technical knowledge
6) Advanced knowledge of applicable quality management and of risk management standards (e.g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.)
7) Advanced knowledge of medical device regulations (MDD 93/42/EEC, MDR 745/2017, etc.)
8) Knowledge of internal and external processes and structures and of the corporate Quality Management requirements
9) Knowledge of sterilization processes, clean room requirements and of validation methods are advantageous · Experience in project managem*******************************************

其他要求

招聘人数：1人
职能类别：医疗器械生产

公司介绍

德国费森尤斯集团是世界500强企业之一，为全球性的医疗保健服务公司，由五个在世界范围内独立运作的事业部组成：费森尤斯医药用品、费森尤斯卡比、费森尤斯医院、费森尤斯工程、费森尤斯生物技术。
费森尤斯医药用品有限公司事业部是当今世界最大的慢性肾衰竭产品和服务的供应商，是全球透析治疗的领导者。目前公司在100多个国家雇有7.9万名员工。作为垂直一体化公司，我们为整个透析价值链提供产品和服务。公司以优质的医疗产品，卓越、可信赖的治疗服务享誉全球。
我们的目标：每天，为全世界的人们创造一个值得生活的未来。
江苏费森尤斯医药用品有限公司是德国费森尤斯集团在中国投资的独资企业。公司成立于2007年7月17日，位于常熟市古里工业园区。公司集研发和生产功能于一体，主要生产用于血液透析的血路管、输液器、透析液、透析器，产品主要面向国际市场销售，部分产品面向国内市场。目前总投资5710万美元，员工1000多人。
由于公司不断增加的新项目和订单需求，现我们诚邀那些勤奋敬业、不断超越自我的专业人才加入我们的团队，共创伟业！
公司提供良好的培训和发展空间，同时您也可以领略到多国文化的和谐共处，提高自己的外语水平和国际视野。另外，公司还提供免费宿舍、免费工作餐及常熟市内／苏州班车、年底绩效奖金、带薪年假及其他欧美独资企业待遇。